Intestinal decontamination with rifaximi

Conditions: iver cirrhosis of any etilogy, complicated by decompensation and classified as Child-Pugh B or C
MedDRA version: 17.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2012-002890-71-DK

Lead Sponsor: Flemming Bendtsen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Patients with decompensated liver cirrhosis and clinical signs of ascites, verified by ultrasonography or CT scan within the last three months.
-Age between 18 and 80 years.
-Portal hypertension and a hepatic venous pressure gradient (HVPG) of 10 mmHg or more.
-Women of child-bearing age should use safe anti conception, defined as either hormonal anti conception or intrauterine device.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

-Child-Pugh Score above 13
-Clinical signs of infection evaluated by blood biochemistry, urine culture and if applicable ascites puncture, and through clinical assessment by the investigator.
-Received antibiotic treatment within 14 days prior to inclusion
-Presence of hepatocellular carcinoma.
-Ongoing invasive cancer or invasive cancer within the last five years,
-Overt hepatic encephalopathy (HE above grade 1),
-Serum creatinine > 200 mmol/l,
-Transfusion requiring bleeding within one week prior to inclusion,
- S-hemoglobin levels of < 5,5 mmol/L
-Severe cardiac, pulmonary or kidney diseases or Type 1 diabetes mellitus,
-Continuous alcohol abuse with symptoms of abstinence
-Expected survival less than 3 months,
- Denied consent